1. Field of the Invention
The invention relates to a method of and device for ensuring the accuracy and efficiency of clear aligner orthodontic therapies as well as increasing patient compliance by reducing discomfort and combining functionality into a breath-freshening medium.
2. Description of Related Art
“Clear aligner therapy” can be defined as any treatment which relies on the continuous wearing of a clear plastic shell, or template, which corresponds to a specific alignment of the dentition that does not quite match the wearer's current alignment, in an effort to improve dental alignment. There are multiple custom fabricated clear aligner therapies available to clinicians. Examples of these include, but are not limited to, Invisalign®, ClearCorrect™, Simpli5™, etc. These therapies are “custom fabricated” because of the precision technology that goes into creating a sequence of aligners which are capable of guiding the progression of alignment in a desirable manner. Clear aligner therapy includes treatment for an individual who recently completed orthodontic therapy of any kind and has been given an Essix® retainer to prevent “relapse.” Essix® retainers are clear plastic shells, provided after braces are removed in order to maintain alignment and occlusal correction post-treatment. “Relapse” refers to any movement of the dentition in a direction away from ideal alignment and usually towards the individual's original malocclusion; this is usually a result of non-compliance with wearing the prescribed retainer. Any relapse of the dentition's alignment will prevent the template from seating fully on the teeth. However, until complete loss of fit occurs, it is sometimes possible to recapture the alignment corresponding to the template with full time wear and some chewing exercises. If this is the prescribed course of treatment, the retainer then becomes a clear aligner.
The processes which can re-align a relapsed dentition are the same as those employed in the previously mentioned clear aligner therapies. Even with recent technological advances in the fabrication of the sequence of aligners, the success of these therapies, much like an attempt at re-alignment via the use of an Essix® retainer, is almost purely reliant on patient cooperation and compliance with the prescribed treatment regimen. Common compliance issues are due to inconvenience, soreness, and bad breath. When compliance is lacking, the first given sequence of aligners is rarely enough to achieve the desired alignment, and the result is a loss of “tracking” somewhere within the given sequence of aligners. Tracking refers to the ability of the given sequence of aligners to keep pace with the simulated and prescribed tooth movement. Any inequity of the computer simulation to the biology and capacity of the individual's teeth to move at the prescribed rate may cause a loss of tracking; or, as previously stated, a simple lack of wearing the aligners as prescribed may also result in a loss of tracking. Even if patient compliance is exemplary, sometimes a loss of tracking will occur if the computer simulation is somehow not reflective of the actual biology and/or ability of the individual's teeth to move at the expected (prescribed) rate. It is sometimes possible to recapture desired tracking by extending the wear time of the aligner which displays the poor tracking; however, without an implement to augment the action of the poorly tracking aligner, it is rarely successful.
When a loss of tracking occurs to the extent that the remaining unused aligners are unusable, using the Invisalign® system as an example, a “refinement” is ordered. A refinement is a new sequence of aligners delivered with the starting point being the current and improved alignment (the result of the first sequence of aligners given up until they no longer were effective) and an end point typically consistent with the originally prescribed end point. Three refinements are included in the initial lab fee paid for by the treating doctor. It is sometimes necessary to exhaust these refinements to satisfy a patient's expectations. The combination of additional refinements and a lengthy, unanticipated treatment time is extremely costly. My use of the terms “clear aligner therapy” and “aligner therapy” is intended also to include such additional refinements involving a new sequence of aligners. The inventor is not aware of aligners that are other than clear, but it is possible that colored aligners may at some point be offered. The applicability of my invention would of course not be affected by a colored, translucent, or opaque aligner and therefore I intend for the definition of “aligner” and “clear aligner” as used herein to include such possible variants.
The typical course of treatment for any clear aligner is for full time wear, except while eating and brushing (or around 22 hours per day as indicated on the Invisalign® website). Advice is given to brush after each meal before placing aligners back onto the teeth. It is not always feasible to follow this advice, and even if it were, food and odors remain in the mouth even after thorough brushing and flossing.
It would be in the best interest of both the treating doctor and the patient to have an auxiliary apparatus which could, with proper use, decrease treatment times and improve patient satisfaction and clinical outcomes. Another advantageous feature of such an apparatus would be seamless integration into the lifestyle of the individual using it, as this would promote compliance. Until now, a few of the available options for such an apparatus included “Chewies™” and “Acceledent®”. “Chewies™” are rubberized cotton rolls which are intended to seat aligners up over the dentition in order to ensure proper fit and “action.” “Action” refers to the flexing of an aligner over the dentition, creating the intended forces necessary for tooth movement into the intended alignment. The use of “Chewies™” is widely prescribed within the orthodontic and general dental profession when clear aligner therapy is provided. “Continued action” is action repeated over extended periods of time.
Moreover, the purpose and necessity of “Chewies” is often lost on a patient because of the foreign nature of the rubbery cotton roll. It is also lost on treating doctors due to expense and an often justified skepticism that the patient will use them. Aligner wearers as well as adolescents wearing Essix® retainers often report bad breath as a reason for non-compliance during the day while they are either at work or school. Furthermore, custom fabricated clear aligner therapies are most appealing due their ability to blend into everyday life. This is not often possible for business professionals, students, or anybody who leads a social and active lifestyle. Thus the orthodontist must address motivation and social relationships from the patient's perspective as part of his or her prescribed treatment.
Acceledent® is a technology which is based on a great deal of research to prove that vibratory action on the dentition during tooth movement can have an acceleratory effect. It consists of a horseshoe shaped arch made of rubber which is connected to an apparatus that sends a vibrating current through the rubber arch. When placed in the mouth between the top and bottom teeth, for 20 minutes daily, treatment times are reported to decrease by ˜50%. The problem with Acceledent® is that it is often cost-prohibitive.
Conventional breath freshening implements are not suitable for use during aligner therapy. Many have convexities to them which often cause them to slip out from within the teeth. Others are flat and, due to the “teetering” effect of a flat object between two opposing points of contact, apply laterally-focused forces onto the aligners instead of vertical “seating” forces. Seating of an aligner refers to the compression of the aligner onto the teeth which is often what applies the prescribed directional forces. Salivary lubrication can also cause them to slip out while attempting to keep them between the teeth. These shortcomings are magnified when aligners are worn due to the smooth and rounded nature of their exterior.
Continued action is difficult to attain with contemporary available therapies. It would be beneficial to all parties involved to have an implement that would promote patient compliance as well as effect tooth movement in a manner aspired to by “Chewies” and Acceledent®, thereby reducing patient and clinician's costs, and improving results and patient satisfaction. The implement for doing so will be embodied by the invention described hereinafter.